Cost of Pharmaceutical Water Systems: Factors, Considerations & Examples

Purified water systems are a major concern for pharmaceutical manufacturing, and pharmaceutical water systems can be expensive.

1. Introduction
2. Cost factors of the following processes:
3. Pretreatment
4. Purified Water Generation Systems
5. Purified Water Storage and Distribution System
6. Mechanical Components and Electrical Components
7. Project Evaluation

 The cost of these pharmaceutical water systems can range from 50 Lakh to 500 Lakh INR. This depends on the quantity and type of contaminants present in the raw water, such as

• the level of total dissolved salts and individual ions in water,
• heavy metals and type, and
• microbiological contamination type and extent.

 The planned capacity of the plant would also have an impact on the expenses of the PW system.

In this article, we will be looking at various factors of how cost-effective a certain system can be over another.

Some of the important factors to be considered in the design of the purified water systems for pharmaceutical manufacturing are:

• Pretreatment
• Purified Water Generation Systems
• Purified Water Storage and Distribution System

 Pretreatment is the most critical but sadly most overlooked component of the entire pharmaceutical water system.

The critical downstream equipment can be safeguarded if this system is properly implemented.

Understanding raw water analysis and designing the pretreatment system is the key to creating the most dependable and accurate purified water producing system.

It would result in less frequent parts replacement, fewer downtime, and consequently less OPEX.

We commonly overlook a significant phase of raw water analysis and continue directly to the filtered water producing system with standard pretreatment.

The prices of water system suppliers that do not analyze the raw water and jump right into a filtered water system are usually cheaper than the prices for vendors who analyze the raw water, study the consumption pattern, and then propose a pretreatment before the purified water system.

Water systems that do not analyze the raw water are cheaper to build but expensive to run.

Understanding the water chemistry and contaminants in the water allows us to provide equipment to remove these impurities one at a time and then feed the right water to the purified water system.

If this is not done, we will have to replace RO membranes, UF membranes, and eventually EDI cells more frequently.

Clients must be educated on the consequences of skipping the necessary pretreatment, which affects OPEX as well as the frequency of breakdowns and maintenance in the plant.

We can save almost 20%-25% of the total OPEX spent every year on the replacement costs if we design the pretreatment accurately with a proper understanding of Water Chemistry.

Physical, dissolved, and microbial contaminants in water should all be studied in raw water analysis.

Experience is also necessary in this case to grasp the groundwater or surface water properties of that source of water in that region.

Understanding the implications of any contamination, whether present or high, is critical before recommending adequate pretreatment.

Typically, the industry implements the most well-known and tested technology for generating purified water, such as ROEDI, while adhering to all pharmacopeial standards.

Without a doubt, this is one of the cleanest and most comprehensive schemes for producing purified water that has been executed in India since 2000.

However, it is essential to recognize that different schemes, such as

1. Demineralization followed by Hot Water Sanitizable Reverse Osmosis/ Ultrafiltration or
2. Reverse Osmosis followed by Demineralization Plant and lastly
3. Hot Water Sanitizable RO/UF

These schemes can be proposed after doing raw water analysis that meets the Purified Water quality as per pharmacopeia. These can sometimes be competitive in CAPEX, and OPEX, and also user-friendly in operation.

The key to finalizing the Purified Water Generation Scheme is to study and select the option that:

1. meets all requirements
2. is most suitable for raw water quality,
3. is user-friendly,
4. competitive in OPEX and CAPEX while maintaining the quality requirements and documentation as per auditing authorities.

Apart from the scheme, important is the selection of components used in the integration of the system.

Wherein other than the material of construction, understanding of following technical specifications becomes significant:

• After-sales services
• Costs of spares

There can be two schemes meeting the pharmacopeia and regulatory audit requirements based on the raw water analysis.

However, the difference between CAPEX can be 25%-35% and OPEX can be much more.

Conversely, most piping contractors who have become pharmaceutical water system integrators would support a single standard approach.

However, I would urge and encourage that some consideration is given to the alternative scheme and recognise the benefits that can help in decreasing CAPEX and OPEX while not sacrificing the ultimate water quality.

Alternative schemes can be proposed by companies that have all of the water treatment solutions or items in their inventory, have extensive experience in water chemistry, and have successfully completed similar projects.

Correct design of the Purified Water Storage and Distribution infrastructure is also essential since lower OPEX can compensate for the higher CAPEX in under 18 months.

Sometimes, plans can be offered that have a lower CAPEX while meeting all the auditors’ requirements for system design, quality, documentation, and validation.

It is essential to collect all data from the customer regarding water usage before building the system with the appropriate storage tank and generation system capacity.

The distribution system is usually over-designed for the capacity of the generation system, or the storage tank capacity is over-designed for the benefit of the system integrator.

They are other examples of inefficient design, such as water starvation at user points or maintaining return line velocities.

Again, all components, from mechanical to electrical to automation, are integrated to create an effective storage and distribution system.

Mechanical Components:

 Important points to be considered for the selection of mechanical components:

• Material of construction
• Sanitary design of these components to meet the guidelines
• The internal finish of the contact parts
• Reliability of components selected
• Accuracy of these components

Electrical Components:

Electrical and instrumentation components selection would cover:

• Accuracy
• The internal finish of the contact parts
• Reliability and ease of regular calibrations
• Availability of spares and service backup
• To meet the latest GAMP requirements.

The selection of Purified Water Storage Capacity, as well as Loop Diameter and Generation Capacity, is crucial to achieving that the user requirement specification is satisfied in terms of the per day/per hour requirements in each user point while keeping the return line velocities as specified.

We have installed a single PW tank with 5 loops, including instrumentation and auto valves, to serve 5 distinct industrial blocks.

By using a single Purified Water Generation System and a single Storage Tank with several looping systems, the CAPEX is reduced by at least 30%-35 percent.

Mother loop and sub-loop systems have been installed, with the possibility of eventual expansion and the inclusion of more user points with the new loop system.

We also optimized loop diameters after learning about the daily requirements. Also, peak loads and thus power conservation by providing the appropriate capacity of the Distribution loop pumps.

When a few user locations require a chilly temperature of the water, we have built POU coolers in WFI loops.

However, when the number of user points requiring cold water is large, we added a Cooling Shell and Tube Double Tube Sheet Heat Exchanger in the supply line to cover all the user points.

The water is then heated to 70°-80°C again via the Heating Shell and Tube Double Tube Sheet Heat Exchanger before being returned to the WFI tank. This saved the cost of purchasing multiple point-of-use coolers.

Proper instrumentation and valve type are also crucial for validating the loop in terms of documentation provided, construction material, and internal finish provided for the sensors and valves in accordance with ASME BPE /ISPE guidelines.

Welding qualification is also an important factor to consider when analyzing the complete PW/WFI loop.

Using proper orbital machines in combination with qualified and experienced welders would ensure accurate weld joints.

This meets all requirements of ASME BPE in terms of concavity/convexity tolerance levels, color charts to be matched for the color of the weld joints, and checking on the quality of weld seams that should not have a “meandering effect.”

The CAPEX for this high-quality orbital welding equipment may be more for the system integrator, but the life cycle ownership costs are substantially lower.

It assures that if the settings established by the qualified welder in the machine are proper, the machine will continue to produce accurate welds.

Similarly, the competence of a programmer is critical when programming the logic in a PLC or SCADA system.

When building and programming software for the control panel of certified systems, it is critical to understand the logic in its entirety.

 How can Aquamech help? 

Aquamech has experience in custom-designing and installing water systems for the pharma and biotech industries, since 1999.

We can assist you through the steps of establishing the best solution with a realistic cost for pharmaceutical water systems.

Visit our website aquamech.co.in or contact our design head Navdeep Singh Sethi.

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